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Biological Collection and Registry of Patients Who Will Have a TAVR (Transcatheter Aortic Valve Replacement) Intervention (BIO TAVI)

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ClinicalTrials.gov Identifier: NCT02812953
Recruitment Status : Recruiting
First Posted : June 24, 2016
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
Action, France

Brief Summary:
A sample of plasma and whole blood will be obtained at 4 time points (pre-procedural, early post-procedural, at hospital discharge and during an eventual visite at 3 or 6 months post-procedural). Test for platelet reactivity (LTA, light transmittance aggregometry and Elisa PRI, Platelet reactivity index), multimeric VWF (von Willebrand factor) and blood level of NET: neutrophil extracellular traps(flow cytometry and ELISA) analyses will be performed at the time of blood sampling. Aliquots of plasma will be stored and frozen for further analyses

Condition or disease
Transcatheter Aortic Valve Replacement

Detailed Description:

There are two major objectives:

  • To correlate changes in VWF, platelet reactivity and blood level of NET after TAVR with clinical outcomes
  • To correlate changes in VWF, platelet reactivity and blood level of NET with antithrombotic regimens after TAVR (direct anticoagulants apixaban versus standard of care, ie Vitamin K antagonist or antiplatelet therapy).

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Actual Study Start Date : May 2016
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022



Primary Outcome Measures :
  1. Major Adverse Cardiac Events [ Time Frame: 12 months ]
    stroke/transient ischemic attack; acute coronary syndrome; hospitalization for cardiac insufficiency, cardiovascular or unexplained deaths will be collected at 12 month by phone contact with the patient or his/her relatives or his/her treating physician

  2. Bleeding [ Time Frame: 12 months ]
    Serious bleeding event (BLEED II or more) will be collected at 12 month by phone contact with the patient or his/her relatives or his/her treating physician


Secondary Outcome Measures :
  1. mean pressure transprosthetic gradient [ Time Frame: within ten days after valve replacement ]
    value of the mean pressure transprosthetic gradient after TAVR procedure will be assessed by TTE (transthoracic echography) or TOE (transesophageal echography)


Biospecimen Retention:   Samples Without DNA
Platelet poor plasma for von Willebrandt Factor further evaluation


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patient undergoing TAVR
Criteria

Inclusion Criteria:

  • patient undergoing TAVR intervention
  • agreement given

Exclusion Criteria:

  • severe thrombopenia ( <40.10^9/L)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02812953


Contacts
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Contact: Jean Philippe COLLET, MD, PhD +33142162962 jean-philippe.collet@aphp.fr
Contact: Delphine Brugier, PhD +33142162918 delphine.brugier-ext@aphp.fr

Locations
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France
Hopital Pitie Salpetriere Recruiting
Paris, France, 75013
Sponsors and Collaborators
Action, France
Additional Information:

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Responsible Party: Action, France
ClinicalTrials.gov Identifier: NCT02812953    
Other Study ID Numbers: 2015-A01832-47
First Posted: June 24, 2016    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided